Labeling of Drug Products for Over-the-Counter Human Use

[[Page 8450]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 330

[Docket No. 92N-454A]

RIN 0910-AA01

Labeling of Drug Products for Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its general labeling policy for over-the-counter (OTC) drug products to

allow for the interchangeable use of certain labeling terms required by

an OTC drug monograph. Examples of words already allowed include:

``doctor'' or ``physician,'' ``consult'' or ``ask,'' and

``indications'' or ``uses.'' This proposal provides an additional

phrase (``unless a doctor tells you'') that can be used in place of

several other phrases found in various OTC drug monographs.

DATES: Written comments by May 20, 1996; written comments on the

agency's economic impact determination by May 20, 1996. The agency is

proposing that any final rule that may issue based on this proposal

become effective 30 days after the date of its publication in the

Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug

Evaluation and Research (HFD-105), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-827-2304.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of April 5, 1993 (58 FR 17553), the agency

proposed to amend its general labeling policy for OTC drug products to

allow for the interchangeable use of certain words in the labeling

required by an OTC drug monograph. The agency had previously proposed

in a number of tentative final monographs and included in a number of

final monographs a provision that the words ``doctor'' and

``physician'' may be used interchangeably in the labeling of OTC drug

products. Instead of including this provision in each OTC drug

monograph, the agency proposed to include such a provision in

Sec. 330.1 (21 CFR 330.1) as part of the general conditions under which

an OTC drug is generally recognized as safe, effective, and not

misbranded. The agency also proposed that, at manufacturers'

discretion, the word ``ask'' could be substituted for the word

``consult,'' which appears in the directions for many OTC drug

monograph ingredients. Thus, the agency proposed that the phrases

``consult a physician,'' ``consult a doctor,'' ``ask a physician,'' and

``ask a doctor'' could be used interchangeably. The agency invited

comments and suggestions as to such other terms that could be used

interchangeably, i.e., terms general in nature that appear in more than

one OTC drug monograph. The comments received in response to the

proposed rulemaking were favorable and suggested a number of additional

terms that could be used interchangeably.

In a final rule published in the Federal Register of January 28,

1994 (59 FR 3998), the agency allowed the following terms to be used

interchangeably in the labeling of OTC drug products: (1) ``Ask'' or

``consult,'' (2) ``assistance'' or ``help,'' (3) ``clean'' or

``cleanse,'' (4) ``continue'' or ``persist,'' (5) ``continues'' or

``persists,'' (6) ``doctor'' or ``physician,'' (7) ``indication'' or

``use,'' (8) ``indications'' or ``uses,'' and (9) ``lung'' or

``pulmonary.'' These terms are included in Sec. 330.1(i).

In the Federal Register of August 3, 1994 (59 FR 39499), the agency

proposed to amend Sec. 330.1(i) so that the phrases ``Drug interaction

precaution,'' ``Avoid mixing drugs,'' or ``Do not mix drugs'' could be

used interchangeably. The agency also requested public comment on

changing the wording of warnings from negative phraseology to a more

positive approach (e.g., ``Do not use more than 7 days'' to ``Use only

7 days,'' ``Do not use in * * *'' to ``Avoid use in * * *,'' ``Do not

use longer than 1 week * * *'' to ``Use only 1 week * * *,'' and ``Do

not use this product except under the advice and supervision of a

physician if * * *,'' to ``Use only with a physician's help if * * *''

or ``Use only with the help of a doctor if * * *'').

The agency has received a number of comments on the proposal, and

they are being evaluated at this time. The agency intends to publish a

final rule in a future issue of the Federal Register.

The agency intends to continue to examine labeling required by OTC

drug monographs to provide consumers more simplified and understandable

information. This includes interchangeable terms, alternative

phraseology, and possibly a new or different labeling format. At this

time, the agency is proposing an additional phrase that could be used

interchangeably.

Labeling information about not using an OTC drug product under

certain circumstances (e.g., ``unless directed by a doctor,'' or

``except under the advice and supervision of a physician'') appears in

different OTC drug monographs in different language. This has occurred

because various OTC advisory review panels recommended different

wording, and OTC drug rulemakings have been completed over a period of

years.

The phrase ``* * * unless directed by a doctor'' appears in the

warning statements of many recent OTC drug monographs. (See, for

example, Sec. 341.76(c)(2) (21 CFR 341.76(c)(2)) which states: ``Do not

use this product if you have * * * unless directed by a doctor.'') In a

number of other monographs, terms with the same (or similar) meaning

have been used. For example, the OTC antacid drug products monograph in

Sec. 331.30(c)(1) and (c)(4) through (c)(7) (21 CFR 331.30(c)(1) and

(c)(4) through (c)(7)) uses the phrase ``except under the advice and

supervision of a physician,'' and the OTC ophthalmic drug products

monograph in Sec. 349.75(c)(2) (21 CFR 349.75(c)(2)) uses the phrase

``except under the advice and supervision of a doctor.'' That

terminology has not been used in more recent OTC drug monographs.

For OTC antihistamine drug products in Sec. 341.72(c)(3) and (c)(4)

(21 CFR 341.72(c)(3) and (c)(4)), and for OTC anorectal drug products

in Sec. 346.50(c)(7)(ii) (21 CFR 346.50(c)(7)(ii)), the phrase ``* * *

without first consulting your doctor'' is used. In Sec. 341.72(c)(6)(i)

through (c)(6)(iii), the phrase ``* * * without first consulting the

child's doctor'' is used. The warning statements for OTC dandruff,

seborrheic dermatitis, and psoriasis drug products in

Sec. 358.750(c)(2)(ii), (c)(3), and (c)(4) (21 CFR 358.750(c)(2)(ii),

(c)(3), and (c)(4)) include the phrases ``* * * without consulting a

doctor,'' ``* * * except on the advice of a doctor,'' and ``* * *

unless directed to do so by a doctor.'' Thus, a number of different

phrases have been used to convey the same message. The phrase ``unless

directed by a doctor'' has been used more recently and most frequently.

The agency believes that all of these phrases can be interpreted in

the same way (e.g., ``* * * unless a doctor tells you''). The agency

believes this simpler phrase may be better understood by consumers than

some of the other phrases. Accordingly, the agency is proposing to

amend Sec. 330.1(i) to include the phrase ``unless a doctor tells you''

as an alternative for these other phrases

[[Page 8451]]

where they appear in the labeling of OTC drug products. In a few

instances, the words ``or your child's doctor'' would be used as part

of this phrase. The agency is asking whether it would be preferable to

say ``your'' child's doctor or ``the'' child's doctor, or whether it

does not make any difference which wording is used. The agency is

requesting comment from manufacturers, health professionals, and

consumers on whether it would be desirable to use this alternative

phrase interchangeably with the other phrases and/or whether a single

uniform phrase should appear in all of the cited regulations. The

agency also seeks comment whether there are additional, simpler,

informative ways in which this information may be stated.

II. Analysis of Impacts

FDA has examined the impacts of the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this proposed rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the proposed

rule is not a significant regulatory action as defined by the Executive

Order and, thus, is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. If this proposed rule becomes a final rule, the

labeling options could be implemented at very little cost by

manufacturers at the next printing of labels, for those products for

which the manufacturer chooses to make a change. Accordingly, the

agency certifies that the proposed rule will not have a significant

economic impact on a substantial number of small entities. Therefore,

under the Regulatory Flexibility Act, no further analysis is required.

The agency invites public comment regarding any substantial or

significant economic impact that this rulemaking would have on the

labeling of OTC drug products. Types of impact may include, but are not

limited to, costs associated with relabeling. Comments regarding the

impact of this rulemaking on OTC drug products should be accompanied by

appropriate documentation. The agency will evaluate any comments and

supporting data that are received and will reassess the economic impact

of this rulemaking in the preamble to the final rule.

III. Paperwork Reduction Act of 1995

FDA tentatively concludes that the labeling requirements proposed

in this document are not subject to review by the Office of Management

and Budget because they do not constitute a ``collection of

information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501

et seq.). Rather, the proposed labeling statements are a ``public

disclosure of information originally supplied by the Federal government

to the recipient for the purpose of disclosure to the public'' (5 CFR

1320.3(c)(2)).

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(c)(6) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

Interested persons may, on or before May 20, 1996, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Written comments on the agency's economic impact

determination may be submitted on or before May 20, 1996. Three copies

of all comments are to be submitted, except that individuals may submit

one copy. Comments are to be identified with the docket number found in

brackets in the heading of this document and may be accompanied by a

supporting memorandum or brief. Received comments may be seen in the

office above between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 330

Over-the-counter drugs.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 330 be amended as follows:

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY

RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

1. The authority citation for 21 CFR part 330 continues to read as

follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

2. Section 330.1 is amended by adding new paragraph (i)(11), to

read as follows:

Sec. 330.1 General conditions for general recognition as safe, -

effective and not misbranded.

* * * * *

(i) * * *-

(11) ``Unless a doctor'' (or ``your child's doctor,'' where

applicable) ``tells you'' may be used in place of any of the following

phrases:

(i) ``Except on the advice of a doctor''.

(ii) ``Except under the advice and supervision of a''

[``physician'' or ``doctor''].

(iii) ``Unless directed by a doctor''.

(iv) ``Unless directed to do so by a doctor''.

(v) ``Without consulting a doctor''.

(vi) ``Without first consulting your'' (or ``your child's'' or

``the child's'') ``doctor''.

* * * * *

Dated: February 23, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-4912 Filed 3-1-96; 8:45 am]

BILLING CODE 4160-01-F